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Siemens Medical Solutions USA, Inc. recalls ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
Recalled February 9, 2022 · FDA recall Z-0547-2022 · Siemens Medical Solutions USA
Hazard
Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a patient's condition. · FDA Class II
Units
1161 systems
Sold at
Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CN, DE, FL, GA, HI, IL, IN, IA, KS, KY, LA, MD, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY. The countries of United Arab Emirates, Armenia, Angola, Austria, Australia, Azerbaijan, Bangladesh, Belgium, Bahrain, Brazil, Switzerland, Chile, China, Colombia, Cyprus, Czech Republic, Germany, Denmark, Dominican Rep., Egypt, Spain, Finland, France, United Kingdom, Georgia, Greece, Guatemala, Hong Kong, Croatia, Indonesia, Israel, Iceland, Italy, Japan, Republic Korea, Kuwait, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Poland, Portugal, Qatar, Romania, Serbia, Russian Fed., Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Turkey, Taiwan, Ukraine, South Africa.
Description
Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a patient's condition.
Product
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
Manufacturer(s)
Siemens Medical Solutions USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →